Medical Device Registry Bill Introduced in House

Two House Democrats Bill Pascrell, Jr. (D-NJ) and Lloyd Doggett (D-TX) have introduced important legislation that would create a national database for medical devices including artitificial hips and knees. The database would allow industry analysts as well as government oversight groups to analyze the medical devices’ effectiveness as well as compaints concerning faulty devices.
There’s been considerable talk and little action for the last decade concerning the establishment of such a registry. The development of a privately-run and industry financed registry has never progressed due in large part to the medical device industry’s unwillingness to finance the project.
The government-run registry will provide the necessary independent oversight as well as play a crucial role in President Obama’s overhaul of healthcare. The “comparative effectiveness” reviews will allow an important analysis of which medical products and procedures are working and most cost effective.
Other countries have oupaced the US in such use of medical device databases where patients receiving artificial medical devices such as hips and knees are registered so that their progress can be determined.
The urgent need for the device database was highlighted last year when Zimmer Holdings, Inc., the country’s most prolific manufacturer of artificial hips and knees, came under scrutiny after doctors had complained to Zimmer that its product, the Zimmer Durom cup was failing at a higher than acceptable rate. In spite of the doctors’ complaints, Zimmer continued to market and sell the Durom cup. While Zimmer was reviewing their data concerning the cup complaints, it’s estimated an additional 1,300 patients received the Durom cup. In response to the NY Times article concerning the device registry, Zimmer officials declined comment on how many patients need revision surgery as a result of the failed Durom cup.
An advocate of the medical device registry, Dr. Henrik Malchau, an orthopedist at Massachusetts General Hospital, told the NY Times that such a device registry could save many patients the pain and suffering of undergoing a revision surgery due to a faulty medical device. Malchau estimated that in countries with no such registry, patients face double the risk of undergoing such risky revision procedures.
In Malchau’s comment’s concerning the Zimmer Durom cup issue, Malchau noted that if the country had had a medical device registry in place at the time doctors were complaining about the Durom cup, the issue could have been resolved far more quickly resulting in fewer patient problems and a decreased number of instances of hip revision surgery.
It’s estimated that the current House proposal would take up to three years to complete and would fall under the control of the Agency for Health Care Research and Control, a division of the Division of Health and Human Services.